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Date Title and Summary Additional Formats
Toggle Summary Vertex Announces European Medicines Agency Marketing Authorization Application Validation for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Triple Combination Treatment in Cystic Fibrosis
- Application supported by positive results from two global Phase 3 studies in people with cystic fibrosis ages 12 and older with one F508del mutation and one minimal function mutation and in people with two F508del mutations - LONDON --(BUSINESS WIRE)--Oct.
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Toggle Summary Vertex Reports Third-Quarter 2019 Financial Results
- Product revenues of $950 million , a 21% increase compared to Q3 2018 - - Continued progression of pipeline of investigational medicines in multiple diseases - BOSTON --(BUSINESS WIRE)--Oct. 30, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial
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Toggle Summary Vertex Announces Agreement with NHS England for Access to All Licensed Cystic Fibrosis Medicines
-Eligible patients in England will have access to ORKAMBI ® (lumacaftor/ivacaftor) and SYMKEVI ® (tezacaftor/ivacaftor), expanded access to KALYDECO ® (ivacaftor)- LONDON --(BUSINESS WIRE)--Oct. 24, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced an access agreement with
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Toggle Summary Vertex to Announce Third-Quarter 2019 Financial Results on October 30
BOSTON --(BUSINESS WIRE)--Oct. 21, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its third quarter 2019 financial results on Wednesday, October 30, 2019 after the financial markets close. The company will host a conference call and webcast at 5:00 p.m. ET .
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Toggle Summary FDA Approves TRIKAFTA™ (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older Who Have at Least One F508del Mutation
- For the first time, approximately 6,000 patients with one minimal function mutation and one F508del mutation have a medicine to treat the underlying cause of their disease– -12,000 people with one or two F508del mutations who are currently eligible for one of Vertex’s three other FDA -approved
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Toggle Summary ADDING MULTIMEDIA FDA Approves TRIKAFTA™ (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older Who Have at Least One F508del Mutation
- For the first time, approximately 6,000 patients with one minimal function mutation and one F508del mutation have a medicine to treat the underlying cause of their disease– -12,000 people with one or two F508del mutations who are currently eligible for one of Vertex’s three other FDA -approved
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Toggle Summary Spanish Government Approves National Reimbursement of ORKAMBI® (lumacaftor/ivacaftor) and SYMKEVI® (tezacaftor/ivacaftor) in Combination With KALYDECO® (ivacaftor)
LONDON --(BUSINESS WIRE)--Oct. 21, 2019-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced that the Spanish Government has approved terms for the national reimbursement of ORKAMBI ® (lumacaftor/ivacaftor) and SYMKEVI ® (tezacaftor/ivacaftor) in combination with KALYDECO ®
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Toggle Summary Vertex Announces Reimbursement of Cystic Fibrosis Medicines SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) for Eligible Patients Ages 12 and Older, and ORKAMBI® (lumacaftor/ivacaftor) in Children Ages 2 to 5, With Certain CFTR Mutations in Australia
LONDON --(BUSINESS WIRE)--Oct. 19, 2019-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced that SYMDEKO ® (tezacaftor/ivacaftor and ivacaftor) is reimbursed in Australia for people with cystic fibrosis (CF) ages 12 years and older who are homozygous for the F508del mutation or who
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Toggle Summary Vertex Receives European CHMP Positive Opinion for KALYDECO® (ivacaftor) to Treat Eligible Infants with Cystic Fibrosis as Early as 6 Months of Age
- If approved, ivacaftor will be the first and only medicine to treat the underlying cause of cystic fibrosis for children this young - LONDON --(BUSINESS WIRE)--Oct. 18, 2019-- Vertex Pharmaceuticals (Europe) Limited today announces that the European Medicines Agency’s (EMA) Committee for
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Toggle Summary Vertex Appoints Carmen Bozic, M.D., as New Chief Medical Officer and Nia Tatsis, Ph.D., as New Chief Regulatory Officer
  BOSTON --(BUSINESS WIRE)--Oct. 1, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Carmen Bozic , M.D., has been appointed as the company’s Executive Vice President, Global Medicines Development and Medical Affairs. Dr.
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Toggle Summary Vertex and Ribometrix Establish Strategic Collaboration to Discover and Develop RNA-Targeted Small Molecule Therapeutics
  -Partnership will leverage Ribometrix’s discovery platform for up to three therapeutic programs-     -Ribometrix to receive $20 million in upfront payment and Vertex equity investment; potential for additional milestones and royalty payments-     BOSTON & DURHAM, N.C. --(BUSINESS WIRE)--Sep.
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Toggle Summary Vertex Announces New Access Agreement with Scottish Government for ORKAMBI® (lumacaftor/ivacaftor) and SYMKEVI® (tezacaftor/ivacaftor)
Eligible patients in Scotland will immediately have access to ORKAMBI (lumacaftor/ivacaftor) and SYMKEVI (tezacaftor/ivacaftor) in combination with ivacaftor LONDON --(BUSINESS WIRE)--Sep. 12, 2019-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced that eligible cystic fibrosis
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Toggle Summary Vertex to Present at the Morgan Stanley Global Healthcare Conference on September 11
BOSTON --(BUSINESS WIRE)--Sep. 10, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that management will present at the Morgan Stanley Global Healthcare Conference on Wednesday, September 11, 2019 at 12:15 p.m. ET . The audio portion of management’s remarks can be accessed
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Toggle Summary Vertex to Acquire Semma Therapeutics With a Goal of Developing Curative Cell-Based Treatments for Type 1 Diabetes
-Semma’s unique investigational approach combines robust production process of pancreatic islet cells with proprietary delivery system to restore insulin secretion in type 1 diabetes patients- -Semma to be acquired for $950 million in cash- BOSTON & CAMBRIDGE, Mass. --(BUSINESS WIRE)--Sep.
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Toggle Summary FDA Accepts New Drug Application for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Combination Treatment
-FDA Grants Priority Review of the application and sets a PDUFA target action date of March 19, 2020 - -Application supported by positive results from two global Phase 3 studies in people with cystic fibrosis ages 12 and older with one F508del mutation and one minimal function mutation and in
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Toggle Summary Vertex Reports Second-Quarter 2019 Financial Results
- Product revenues of $940 million , a 25% increase compared to 2018 - - Company increases full-year 2019 total product revenue guidance to $3.6 to $3.7 billion - - Company advancing programs in 5 additional diseases beyond cystic fibrosis - BOSTON --(BUSINESS WIRE)--Jul.
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Toggle Summary Vertex Announces Dr. Jeffrey Leiden to Transition to Role of Executive Chairman, Effective April 1, 2020 and Dr. Reshma Kewalramani Appointed as New Chief Executive Officer
BOSTON --(BUSINESS WIRE)--Jul. 25, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that its Board of Directors has approved the planned transition of Chairman, President and Chief Executive Officer Jeffrey Leiden , M.D., Ph.D, into the role of Executive Chairman of the
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Toggle Summary Vertex Submits New Drug Application to the U.S. FDA for Triple Combination Regimen of VX-445 (Elexacaftor), Tezacaftor and Ivacaftor in Cystic Fibrosis
-Application supported by positive results from two global Phase 3 studies in people with CF ages 12 and older with one F508del mutation and one minimal function mutation and in people with two F508del mutations- BOSTON --(BUSINESS WIRE)--Jul. 22, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq:
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Toggle Summary Vertex to Announce Second-Quarter 2019 Financial Results on July 31
BOSTON --(BUSINESS WIRE)--Jul. 17, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its second quarter 2019 financial results on Wednesday, July 31, 2019 after the financial markets close. The company will host a conference call and webcast at 4:30 p.m. ET .
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Toggle Summary FDA Approves SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of CF in Children Ages 6-11 Years with Certain Mutations in the CFTR Gene
-SYMDEKO is now approved for patients 6 years of age and older with two copies of the F508del mutation or one copy of a responsive mutation- -Vertex's third medicine approved to treat the underlying cause of CF in eligible patients in this age range- BOSTON --(BUSINESS WIRE)--Jun.
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Toggle Summary Vertex Expands into New Disease Areas and Enhances Gene Editing Capabilities Through Expanded Collaboration with CRISPR Therapeutics and Acquisition of Exonics Therapeutics
-Provides Vertex with leading gene editing capabilities to develop novel therapies for Duchenne Muscular Dystrophy and Myotonic Dystrophy Type 1- -CRISPR to receive an upfront payment of $175 million , with potential for additional milestone and royalty payments- -Exonics to be acquired for an
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Toggle Summary Vertex to Present Data at ECFS Conference on Potential Impact of Early Treatment and Long-Term Treatment with CFTR Modulators on the Underlying Cause of CF
BOSTON --(BUSINESS WIRE)--Jun. 4, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that data from six scientific abstracts from the company’s portfolio of cystic fibrosis (CF) medicines will be presented at the 42 nd European Cystic Fibrosis Conference , taking place June
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Toggle Summary Vertex Selects Triple Combination Regimen of VX-445, Tezacaftor and Ivacaftor to Submit for Global Regulatory Approvals in Cystic Fibrosis
-Mean absolute improvement in ppFEV 1 of 14.3 percentage points from baseline through week 24 of treatment compared to placebo (p
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Toggle Summary Vertex and Kymera Therapeutics Establish Strategic Collaboration to Discover and Develop Targeted Protein Degradation Medicines for Serious Diseases
-Multi-year collaboration leveraging Kymera’s proprietary targeted protein degradation platform to develop novel medicines- -Kymera to receive $70 million upfront, including equity investment, and potential additional milestone and royalty payments for up to six programs in the collaboration-
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Toggle Summary Vertex Reports First-Quarter 2019 Financial Results
- First-quarter 2019 product revenues of $857 million , a 34% increase compared to $638 million in 2018- - First-quarter 2019 GAAP operating income increased 115% to $277 million ; non-GAAP operating income increased 81% to $377 million - - On track to choose best triple combination regimen in Q2
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Toggle Summary FDA Approves KALYDECO® (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants with CF as Early as Six Months of Age
-Opportunity to treat the underlying cause of CF earlier than ever before- -Safety data from Phase 3 ARRIVAL study support treatment with KALYDECO in children ages six to
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Toggle Summary CRISPR Therapeutics and Vertex Announce FDA Fast Track Designation for CTX001 for the Treatment of Beta Thalassemia
ZUG, Switzerland and CAMBRIDGE and BOSTON, Mass. – April 16, 2019 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CTX001 for the
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Toggle Summary Vertex to Announce First-Quarter 2019 Financial Results on April 30
BOSTON --(BUSINESS WIRE)--Apr. 12, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its first quarter 2019 financial results on Tuesday, April 30, 2019 after the financial markets close. The company will host a conference call and webcast at 4:30 p.m. ET .
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Toggle Summary Vertex Appoints Charles Wagner as Chief Financial Officer
BOSTON --(BUSINESS WIRE)--Apr. 2, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the appointment of Charles (Charlie) Wagner as Executive Vice President and Chief Financial Officer (CFO), effective April 10, 2019 . Mr. Wagner will report directly to Vertex Chairman,
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Toggle Summary Vertex Receives Approval for SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) in Australia, to Treat the Underlying Cause of Cystic Fibrosis in People aged 12 and Older with Certain CFTR Gene Mutations
-A new treatment option for patients with two copies of the F508del mutation, the most common mutation in cystic fibrosis- -First medicine in Australia to treat the underlying cause of cystic fibrosis in patients who have certain mutations that result in residual CFTR function- BOSTON --(BUSINESS
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Toggle Summary Two Phase 3 Studies of the Triple Combination of VX-445, Tezacaftor and Ivacaftor Met Primary Endpoint of Improvement in Lung Function (ppFEV1) in People with Cystic Fibrosis
-Mean absolute improvement in ppFEV 1 of 13.8 percentage points from baseline at week 4 in people with one F508del mutation and one minimal function mutation (F/MF) compared to placebo (p
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Toggle Summary CRISPR Therapeutics and Vertex Announce Progress in Clinical Development Programs for the Investigational CRISPR/Cas9 Gene-Editing Therapy CTX001
-First patient infused with CTX001 in a Phase 1/2 clinical trial for patients with beta thalassemia- -First patient enrolled in a Phase 1/2 clinical trial of CTX001 for patients with sickle cell disease- ZUG, Switzerland and CAMBRIDGE and BOSTON, Mass., Feb.
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Toggle Summary Vertex Appoints Lloyd Carney to its Board of Directors
BOSTON --(BUSINESS WIRE)--Feb. 21, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Lloyd Carney has been appointed to its board of directors as an independent director. Mr. Carney is a prominent technology executive with experience leading innovative, high-growth
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Toggle Summary Positive Phase 3 Study for Tezacaftor/Ivacaftor Combination in Children Aged 6-11 Years with Cystic Fibrosis Supports European Medicines Agency Submission
-Study met primary endpoint with a statistically significant improvement in absolute change in lung clearance index (LCI 2.5 ) through 8 weeks of tezacaftor/ivacaftor treatment- -Tezacaftor in combination with ivacaftor was generally well tolerated and safety data were consistent with previous
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Toggle Summary Vertex Reports Full-Year and Fourth-Quarter 2018 Financial Results
- Full-year 2018 CF product revenues of $3.04 billion , a 40% increase compared to $2.17 billion in 2017; fourth-quarter 2018 CF product revenues of $868 million - - Full-year 2018 GAAP operating income increased 415% to $635 million ; non-GAAP operating income increased 97% to $1.11 billion - -
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Toggle Summary Health Canada Grants Market Authorization for KALYDECO® (ivacaftor) in Children Ages 12 to <24 months with Certain Mutations in the CFTR Gene
-KALYDECO is the first and only approved medicine in Canada to treat the underlying cause of cystic fibrosis in these young patients- BOSTON --(BUSINESS WIRE)--Jan. 28, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Health Canada has granted Market Authorization for
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Toggle Summary Vertex Announces Departure of Ian Smith, Names Interim CFO
BOSTON --(BUSINESS WIRE)--Jan. 23, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Ian Smith has been terminated as Chief Operating Officer and interim Chief Financial Officer (CFO) effective immediately. Mr. Smith’s termination is the result of personal behavior that
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Toggle Summary Vertex to Announce Full-Year and Fourth-Quarter 2018 Financial Results on February 5
BOSTON --(BUSINESS WIRE)--Jan. 22, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its full year and fourth quarter 2018 financial results on Tuesday, February 5, 2019 after the financial markets close. The company will host a conference call and webcast at 4:30 p.m. ET .
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Toggle Summary Vertex Announces European Commission Approval for ORKAMBI® (lumacaftor/ivacaftor) for Treatment of Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease
Lumacaftor/ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic fibrosis for approximately 1,500 children aged 2 to 5 with two copies of the F508del mutation LONDON --(BUSINESS WIRE)--Jan. 21, 2019-- Vertex Pharmaceuticals (Europe) Limited today
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Toggle Summary CRISPR Therapeutics and Vertex Announce FDA Fast Track Designation for CTX001 for the Treatment of Sickle Cell Disease
ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, Jan. 04, 2019 (GLOBE NEWSWIRE) -- CRISPR Therapeutics&nbsp;(NASDAQ:CRSP) and Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CTX001 for the
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Toggle Summary Vertex and Arbor Biotechnologies Establish Collaboration to Discover Novel Proteins to Advance Discovery of Gene-Editing Therapies
-Multi-year research collaboration funded by Vertex using Arbor’s proprietary research platform to enhance efforts in developing gene-editing therapies in five diseases- -Arbor to receive up-front cash payment and convertible note investment, research funding, and potential for additional
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Toggle Summary Vertex to Present at the J.P. Morgan Healthcare Conference on January 7
BOSTON --(BUSINESS WIRE)--Jan. 2, 2019-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that management will present at the J.P. Morgan Healthcare Conference on Monday, January 7, 2019 at 2:30 p.m. ET ( 11:30 a.m. PT ). The audio portion of management’s remarks can be accessed
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Toggle Summary Vertex Announces it will Submit Cystic Fibrosis Medicines ORKAMBI® (lumacaftor/ivacaftor) as well as SYMKEVI® (tezacaftor/ivacaftor) to be Used in Combination with ivacaftor, to the Scottish Medicines Consortium for Appraisal
- If accepted by the Scottish Medicines Consortium (SMC) for use on the NHS in Scotland , eligible patients could have access to these precision cystic fibrosis medicines in 2019 - - While the SMC reviews the submissions, clinicians can apply for access to these CF medicines via the PACS Tier 2
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Toggle Summary Vertex Announces Positive Phase 2 Data in Third Proof-of-Concept Study with the NaV1.8 Inhibitor VX-150
-Treatment with the NaV1.8 inhibitor VX-150 showed significant relief of pain in patients with small fiber neuropathy and was generally well tolerated- -Third positive Phase 2 proof-of-concept study for VX-150 further validates the potential role of NaV1.8 inhibition for the treatment of multiple
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Toggle Summary Health Canada Grants Market Authorization for ORKAMBI® (lumacaftor/ivacaftor) for Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease
- ORKAMBI is the first medicine in Canada to treat the underlying cause of CF in young children with two copies of the F508del mutation - BOSTON --(BUSINESS WIRE)--Dec. 13, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced that Health Canada has granted Market Authorization
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Toggle Summary Vertex Announces European Commission Approval for KALYDECO® (ivacaftor) to Treat Patients with Cystic Fibrosis Aged 12 to <24 months with Certain Mutations in the CFTR Gene
Ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic fibrosis in these young patients LONDON --(BUSINESS WIRE)--Nov. 29, 2018-- Vertex Pharmaceuticals (Europe) Limited today announced that the European Commission has granted approval of the label
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Toggle Summary Two Phase 3 Studies of the Triple Combination of VX-659, Tezacaftor and Ivacaftor Met Primary Endpoint of Improvement in Lung Function (ppFEV1) in People with Cystic Fibrosis
-Mean absolute improvement in ppFEV 1 of 14.0 percentage points from baseline at week 4 in people with one F508del mutation and one minimal function mutation compared to placebo (p
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Toggle Summary Vertex Receives European CHMP Positive Opinion for ORKAMBI® (lumacaftor/ivacaftor) for Treatment of Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease
- If approved, lumacaftor/ivacaftor will be the first medicine in Europe to treat the underlying cause of cystic fibrosis for approximately 1,500 young children with two copies of the F508del mutation - LONDON --(BUSINESS WIRE)--Nov. 16, 2018-- Vertex Pharmaceuticals (Europe) Limited today
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Toggle Summary Vertex Announces European Authorization for Third Cystic Fibrosis Medicine SYMKEVI® (tezacaftor/ivacaftor), to be used in combination with ivacaftor (KALYDECO®), for People with CF Aged 12 and Older with Certain Mutations in the CFTR gene
- A new treatment option for patients with two copies of the F508del mutation, the most common mutation in cystic fibrosis - - First medicine in the EU to treat the CFTR protein defect in patients who have one copy of the F508del mutation and one copy of one of 14 mutations that result in residual
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Toggle Summary Vertex Reports Third-Quarter 2018 Financial Results
-Third-quarter 2018 total CF product revenues of $783 million , a 42% increase compared to $550 million in the third quarter of 2017- -Company reiterates full-year 2018 total CF product revenue guidance of $2.9 to $3.0 billion ; reiterates full-year 2018 combined non-GAAP R&amp;D and SG&amp;A expense
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